An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients

NCT01661829 | Completed DMC

• 2 other identifiers: KSVHCRC trial-01Colorectal disease
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

In patients who underwent sphincter preserving surgery with toal mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal function after stoma closure.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of anterior resection syndrome after stoma closure

  1 year after stoma closure

Study Arms (2)

Biofeedback

Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy)

Kegel

Patients will be trained to take excersise for their anal sphincter by Kegel.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Rectal cancer patients who underwent sphincter saving surgery with total mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy.

You may qualify if:

• rectal cancer patients
• neoadjuvant chemoradiation therapy (+)
• sphincter saving surgery with total mesorectal excision (+)
• temporary loop stoma (+)
• adult who is 17 years or older
• patinet who aggree with our study
• if woman is childbearing age, her pregnancy test shoud be indentified 'negative'

You may not qualify if:

• patients who have been enrolled to other clinical studies related to this study
• patients who underwent diverting stoma before neoadjuvant chemoradiation
• temporary end -ostomy (+)
• uncontrolled metabolic or systemic disease
• patients who do not understand the purpose of this study because of dementia or pshycologic problem
• MRSA or Clostridium difficille (+)
• Pregnant or during breast feeding
• serious complication after sphincter saving surgery

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea

Suwon, 442-723, South Korea

Location

Related Publications (2)

• Cho HM, Kim H, Yoo R, Kim G, Kye BH. Effect of Biofeedback Therapy during Temporary Stoma Period in Rectal Cancer Patients: A Prospective Randomized Trial. J Clin Med. 2021 Nov 4;10(21):5172. doi: 10.3390/jcm10215172.

  PMID: 34768692 DERIVED

• Kye BH, Kim HJ, Kim G, Yoo RN, Cho HM. The Effect of Biofeedback Therapy on Anorectal Function After the Reversal of Temporary Stoma When Administered During the Temporary Stoma Period in Rectal Cancer Patients With Sphincter-Saving Surgery: The Interim Report of a Prospective Randomized Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3611. doi: 10.1097/MD.0000000000003611.

  PMID: 27149496 DERIVED

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor

Study Record Dates

• First Submitted: August 5, 2012
• First Posted: August 10, 2012
• Study Start: March 1, 2012
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: February 4, 2015

Record last verified: 2015-02

Locations

KR (1)